Drugs List

Therapeutic Indications

Uses

Active psoriatic arthritis
Juvenile rheumatoid arthritis
Plaque psoriasis
Rheumatoid arthritis
Severe active axial spondyloarthritis

Rheumatoid arthritis
Moderate to severe active rheumatoid arthritis in adults who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate. Used in combination with methotrexate. Monotherapy can be considered where methotrexate is contraindicated or not tolerated.

Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Juvenile idiopathic arthritis
Active polyarthritis and extended oligoarthritis in children from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Enthesitis-related arthritis in children from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Psoriatic arthritis
Active and progressive psoriatic arthritis in adults who have had an inadequate response to previous DMARDs.

Axial spondyloarthritis
Severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Severe non-radiographic axial spondyloarthritis in adults, with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDS).

Plaque psoriasis
Moderate to severe plaque psoriasis in adults who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including ciclosporin, methotrexate or PUVA.

Chronic severe plaque psoriasis in children from the age of 6 years who have had an inadequate response to, or are intolerant of, other systemic therapies or phototherapies.

Administration

For subcutaneous injection only.

Contraindications

Children under 2 years
Infection
Potential sepsis
Sepsis
Breastfeeding
Pregnancy
Tuberculosis

Precautions and Warnings

History of recurrent infection
Immunosuppression
Predisposition to demyelinating disorder
Predisposition to infection
Suspected infection
Alcoholic liver disease
Central nervous system demyelinating disorder
Congestive cardiac failure
Diabetes mellitus
Hepatitis B
Hepatitis C
History of haematological disorder
History of malignant melanoma
History of tuberculosis
Latent or healed tuberculosis
Malignant melanoma

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Administration of live vaccines is not recommended
Consider prophylactic immunoglobulin if exposure to varicella virus
May mask symptoms or signs of infections
Before initiating screen all patients for hepatitis B infection
Before starting therapy ensure immunisations are up to date in children
Monitor patients for non-melanoma skin cancer prior to and during treatment
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Not all available strengths are licensed for all indications
Prior to starting therapy rule out active tuberculosis
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex in some brands
Record name and batch number of administered product
Monitor closely any patient who develops new infection while on treatment
Monitor for HBV reactivation during therapy and for several weeks after
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor for worsening hepatitis C infection
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Immunosuppressive drugs may increase risk of malignancy
Reactivation of hepatitis B may occur in chronic carriers
Risk of developing opportunistic infections
Discontinue if blood dyscrasia develops
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue treatment if patient develops a serious infection
Discontinue treatment temporarily in event of exposure to varicella virus
Female: Contraception required during and for 3 weeks after treatment
Remind patient of importance of carrying Alert Card with them at all times

Serious infections have been reported in patients using etanercept. Screen patients for the presence of infections prior to initiating treatment. If active infections (including chronic infections) are identified, delay treatment initiation. Continue to monitor patients for infections during treatment and, due to the long elimination half life, after treatment is discontinued. Where infections develop during treatment, monitor patients closely for potential deterioration. If infections are serious, discontinue etanercept.

Reported infections have included tuberculosis. Pre-treatment infection screening should include evaluation for active or latent (inactive) tuberculosis. Assessment should include an extensive history and appropriate screening tests (consult product information for details). Results should be documented on the patient's alert card. If active tuberculosis is identified, do not initiate etanercept. If latent (inactive) tuberculosis is identified, etanercept can be initiated with caution provided anti-tuberculosis medication is used. Continue to monitor patients during and for several months after discontinuing treatment. Advise patients to report signs/symptoms suggestive of tuberculosis (persistent cough, wasting/weight loss, low grade fever).

Reactivation of hepatitis B virus (HBV) in previously infected patients has been reported. If HBV infection is detected, discuss ongoing management with an appropriate specialist. Monitor HBV carriers for signs of active infection during and for several weeks after treatment. If HBV infection occurs during treatment, discontinue etanercept and initiate appropriate supportive therapy.

Pregnancy and Lactation

Pregnancy

Etanercept is contraindicated during pregnancy.

The manufacturer does not recommend using etanercept during pregnancy. A higher rate of major birth defects have been reported in one study with exposure to etanercept during the first trimester. A further study showed no increased risk of major adverse outcomes and no increased risk of minor birth defects, preterm birth, stillbirth or infection in the first year for infants of women exposed to etanercept during pregnancy.

Administration of live vaccines to infants for 16 weeks after the mother's last dose of etanercept is generally not recommended.

Lactation

Etanercept is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues etanercept or discontinues breastfeeding. Available data indicates etanercept is expressed in human breast milk, but the quantity is unknown. Effects on exposed infants are unknown.

Side Effects

Abscess
Acute appendicitis
Allergic reaction
Anaemia
Anaphylactic reaction
Angioedema
Antibody formation
Aplastic anaemia
Aseptic meningitis
Autoimmune disorders
Autoimmune hepatitis
Bacteraemia
Bronchitis
Bronchospasm
Bursitis
Cellulitis
Cholecystitis
CNS demyelinating event
Congestive cardiac failure
Cutaneous lupus erythematosus
Cutaneous vasculitis
Cystitis
Demyelinating disorders
Depression
Diabetes mellitus
Diverticulitis
Elevation of liver enzymes
Endocarditis
Erythema multiforme
Fever
Gastrointestinal disorder
Guillain-Barre syndrome
Headache
Herpes zoster
Increased susceptibility to parasitic infections
Inflammatory bowel disease
Injection site reactions
Interstitial lung disease
Kaposi's Sarcoma
Leg ulcers
Leucopenia
Leukaemia
Lichenoid rash
Listeriosis
Lupus erythematosus-like syndrome
Lymphoma
Macrophage-activation syndrome
Malignancies
Malignant melanoma
Myositis (reversible)
Neoplasms
Neutropenia
Non melanoma skin cancer
Oesophagitis
Opportunistic infections
Optic neuritis
Osteomyelitis
Otitis media
Pancytopenia
Peritonitis
Pneumonia
Pneumonitis
Pruritus
Psoriasiform rash
Psoriasis
Pulmonary fibrosis
Pyelonephritis
Rash
Reactivation of hepatitis B
Sarcoidosis
Scleritis
Seizures
Sepsis
Septic arthritis
Septic shock
Sinusitis
Skin carcinoma
Skin disorder
Skin infection
Skin ulcer
Stevens-Johnson syndrome
Streptococcal fasciitis
Thrombocytopenia
Toxic epidermal necrolysis
Transverse myelitis
Tuberculosis
Upper respiratory tract infection
Urinary tract infections
Urticaria
Uveitis
Vasculitis

Presentation

Injections of etanercept.

Drugs List

Therapeutic Indications

Uses

Active psoriatic arthritis
Juvenile rheumatoid arthritis
Plaque psoriasis
Rheumatoid arthritis
Severe active axial spondyloarthritis

Rheumatoid arthritis
Moderate to severe active rheumatoid arthritis in adults who have had an inadequate response to disease-modifying antirheumatic drugs (DMARDs), including methotrexate. Used in combination with methotrexate. Monotherapy can be considered where methotrexate is contraindicated or not tolerated.

Severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Juvenile idiopathic arthritis
Active polyarthritis and extended oligoarthritis in children from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Enthesitis-related arthritis in children from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy.

Psoriatic arthritis
Active and progressive psoriatic arthritis in adults who have had an inadequate response to previous DMARDs.

Axial spondyloarthritis
Severe active ankylosing spondylitis in adults who have had an inadequate response to conventional therapy.

Severe non-radiographic axial spondyloarthritis in adults, with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDS).

Plaque psoriasis
Moderate to severe plaque psoriasis in adults who have failed to respond to, have a contraindication to, or are intolerant of other systemic therapies including ciclosporin, methotrexate or PUVA.

Chronic severe plaque psoriasis in children from the age of 6 years who have had an inadequate response to, or are intolerant of, other systemic therapies or phototherapies.

Dosage

Adults

Children

Administration

For subcutaneous injection only.

Contraindications

Children under 2 years
Infection
Potential sepsis
Sepsis
Breastfeeding
Pregnancy
Tuberculosis

Precautions and Warnings

History of recurrent infection
Immunosuppression
Predisposition to demyelinating disorder
Predisposition to infection
Suspected infection
Alcoholic liver disease
Central nervous system demyelinating disorder
Congestive cardiac failure
Diabetes mellitus
Hepatitis B
Hepatitis C
History of haematological disorder
History of malignant melanoma
History of tuberculosis
Latent or healed tuberculosis
Malignant melanoma

Adjustment of hypoglycaemic therapy may be necessary in diabetes mellitus
Administration of live vaccines is not recommended
Consider prophylactic immunoglobulin if exposure to varicella virus
May mask symptoms or signs of infections
Before initiating screen all patients for hepatitis B infection
Before starting therapy ensure immunisations are up to date in children
Monitor patients for non-melanoma skin cancer prior to and during treatment
Not all available brands are licensed for all age groups
Not all available brands are licensed for all indications
Not all available strengths are licensed for all indications
Prior to starting therapy rule out active tuberculosis
Prior to starting therapy screen for latent tuberculosis
Treat and control infections prior to commencing therapy
Treatment to be initiated and supervised by a specialist
Needle cover contains a derivative of latex in some brands
Record name and batch number of administered product
Monitor closely any patient who develops new infection while on treatment
Monitor for HBV reactivation during therapy and for several weeks after
Monitor for signs of blood dyscrasias eg fever, sore throat, malaise etc
Monitor for worsening hepatitis C infection
Advise patient to report unexplained fever, sore throat, bruising, bleeding
Advise patient to seek med advice if signs/symptoms of tuberculosis develop
Immunosuppressive drugs may increase risk of malignancy
Reactivation of hepatitis B may occur in chronic carriers
Risk of developing opportunistic infections
Discontinue if blood dyscrasia develops
Discontinue if serious allergic or anaphylactic reaction occurs
Discontinue treatment if patient develops a serious infection
Discontinue treatment temporarily in event of exposure to varicella virus
Female: Contraception required during and for 3 weeks after treatment
Remind patient of importance of carrying Alert Card with them at all times

Serious infections have been reported in patients using etanercept. Screen patients for the presence of infections prior to initiating treatment. If active infections (including chronic infections) are identified, delay treatment initiation. Continue to monitor patients for infections during treatment and, due to the long elimination half life, after treatment is discontinued. Where infections develop during treatment, monitor patients closely for potential deterioration. If infections are serious, discontinue etanercept.

Reported infections have included tuberculosis. Pre-treatment infection screening should include evaluation for active or latent (inactive) tuberculosis. Assessment should include an extensive history and appropriate screening tests (consult product information for details). Results should be documented on the patient's alert card. If active tuberculosis is identified, do not initiate etanercept. If latent (inactive) tuberculosis is identified, etanercept can be initiated with caution provided anti-tuberculosis medication is used. Continue to monitor patients during and for several months after discontinuing treatment. Advise patients to report signs/symptoms suggestive of tuberculosis (persistent cough, wasting/weight loss, low grade fever).

Reactivation of hepatitis B virus (HBV) in previously infected patients has been reported. If HBV infection is detected, discuss ongoing management with an appropriate specialist. Monitor HBV carriers for signs of active infection during and for several weeks after treatment. If HBV infection occurs during treatment, discontinue etanercept and initiate appropriate supportive therapy.

Pregnancy and Lactation

Pregnancy

Etanercept is contraindicated during pregnancy.

The manufacturer does not recommend using etanercept during pregnancy. A higher rate of major birth defects have been reported in one study with exposure to etanercept during the first trimester. A further study showed no increased risk of major adverse outcomes and no increased risk of minor birth defects, preterm birth, stillbirth or infection in the first year for infants of women exposed to etanercept during pregnancy.

Administration of live vaccines to infants for 16 weeks after the mother's last dose of etanercept is generally not recommended.

Lactation

Etanercept is contraindicated during breastfeeding.

The manufacturer advises that the patient either discontinues etanercept or discontinues breastfeeding. Available data indicates etanercept is expressed in human breast milk, but the quantity is unknown. Effects on exposed infants are unknown.

Side Effects

Abscess
Acute appendicitis
Allergic reaction
Anaemia
Anaphylactic reaction
Angioedema
Antibody formation
Aplastic anaemia
Aseptic meningitis
Autoimmune disorders
Autoimmune hepatitis
Bacteraemia
Bronchitis
Bronchospasm
Bursitis
Cellulitis
Cholecystitis
CNS demyelinating event
Congestive cardiac failure
Cutaneous lupus erythematosus
Cutaneous vasculitis
Cystitis
Demyelinating disorders
Depression
Diabetes mellitus
Diverticulitis
Elevation of liver enzymes
Endocarditis
Erythema multiforme
Fever
Gastrointestinal disorder
Guillain-Barre syndrome
Headache
Herpes zoster
Increased susceptibility to parasitic infections
Inflammatory bowel disease
Injection site reactions
Interstitial lung disease
Kaposi's Sarcoma
Leg ulcers
Leucopenia
Leukaemia
Lichenoid rash
Listeriosis
Lupus erythematosus-like syndrome
Lymphoma
Macrophage-activation syndrome
Malignancies
Malignant melanoma
Myositis (reversible)
Neoplasms
Neutropenia
Non melanoma skin cancer
Oesophagitis
Opportunistic infections
Optic neuritis
Osteomyelitis
Otitis media
Pancytopenia
Peritonitis
Pneumonia
Pneumonitis
Pruritus
Psoriasiform rash
Psoriasis
Pulmonary fibrosis
Pyelonephritis
Rash
Reactivation of hepatitis B
Sarcoidosis
Scleritis
Seizures
Sepsis
Septic arthritis
Septic shock
Sinusitis
Skin carcinoma
Skin disorder
Skin infection
Skin ulcer
Stevens-Johnson syndrome
Streptococcal fasciitis
Thrombocytopenia
Toxic epidermal necrolysis
Transverse myelitis
Tuberculosis
Upper respiratory tract infection
Urinary tract infections
Urticaria
Uveitis
Vasculitis

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: December 2020

Reference Sources

Summary of Product Characteristics: Benepali 25mg solution for injection in pre-filled syringe. Biogen Idec Ltd. Revised November 2019.
Summary of Product Characteristics: Benepali 50mg solution for injection in pre-filled syringe. Biogen Idec Ltd. Revised November 2019.
Summary of Product Characteristics: Benepali 50mg solution for injection in pre-filled pen. Biogen Idec Ltd. Revised November 2019.

Summary of Product Characteristics: Enbrel 10mg powder and solvent for solution for injection for paediatric use. Pfizer Ltd. Revised September 2020.
Summary of Product Characteristics: Enbrel 25mg powder and solvent for solution for injection. Pfizer Ltd. Revised September 2020.
Summary of Product Characteristics: Enbrel 25mg solution for injection in pre-filled syringe. Pfizer Ltd. Revised September 2020.
Summary of Product Characteristics: Enbrel 25mg solution for injection in pre-filled pen. Pfizer Ltd. Revised September 2020.
Summary of Product Characteristics: Enbrel 50mg solution for injection in pre-filled syringe. Pfizer Ltd. Revised September 2020.
Summary of Product Characteristics: Enbrel 50mg solution for injection in pre-filled pen. Pfizer Ltd. Revised September 2020.

Summary of Product Characteristics: Erelzi 25mg and 50mg solution for injection in pre-filled syringe and Erelzi 50mg solution for injection in pre-filled pen. Sandoz Limited. Revised October 2020.